Medtronic · 13 hours ago
Senior Software Engineering Program Manager, Design Quality Center of Expertise
Mounds View, MN
Full-time
Onsite
Senior Level
$150K/yr - $224K/yr
7+ years expMedtronic is a global leader in healthcare technology, seeking a Senior Software Engineering Program Manager to drive product development processes and enhance software design control capabilities. In this role, you will lead enterprise-wide initiatives to ensure product quality and regulatory compliance while coaching cross-functional teams throughout the organization.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Lead enterprise-wide initiatives with emphasis on Design, Reliability & Manufacturability/Maintainability (DRM) to ensure product quality, regulatory compliance and operational excellence across all Medtronic Operating Units (OU)
Apply your technical expertise to Put Patients First every day
Apply Design for Reliability and Design for Manufacturability principles to reduce risk, improve First Time Quality (FTQ), and enable efficient design transfer
Guide cross-functional teams through the Product Development Process (PDP) with a strong focus on positive design control outcomes and regulatory adherence
Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), ensuring field performance insights are incorporated into early design phases
Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts from concept through commercialization
Leverage biomedical engineering knowledge to ensure designs meet functional, safety, and efficacy requirements in compliance with medical device standards
Maintain deep familiarity with FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO14971 and other design control regulations, providing expert guidance on compliance throughout the development lifecycle
Partner closely with R&D and Quality colleagues to embed best practices in technical rigor, simplify execution, and bring forward individual perspectives that strengthen decision-making and solution design
Conduct / support software engineering capability assessments to drive continuous improvement initiatives and organizational knowledge sharing
Improve product quality, regulatory compliance, and operational excellence across all Operating Units (OUs)
Serve as subject matter expert for:
CAPA
Post‑Market Surveillance (PMS)
Incorporation of field performance data into early design phases
Provide hands‑on coaching to engineering, quality, and cross‑functional teams to strengthen Software Design Control maturity across Medtronic
Qualification
Required
Bachelor's Degree with 7+ years of work experience in Quality and/or Development, with 5+ years of managerial experience
OR Advanced Degree with 5+ years of work experience in Quality and/or Development, with 5+ years of managerial experience
Preferred
Experience with traditional staged software development life cycles, as well as incremental / Agile development life cycles
Experience leading complex projects/programs
Experience with SPC, CAPA, NCMR, PDP processes
Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously
Ability to establish and maintain a trusted role with the various stakeholders in coordinating multiple functions across the organization
Working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485
Working knowledge of Software Development Standards such as IEC 62304, IEC 82304, and IEC 81001-5-1
Green Belt Six Sigma/DRM Training/Certification
Effective verbal and written communication, analytical, influencing and interpersonal skills
Demonstrated working knowledge of process validation, statistical methods, risk management, software engineering best practices
Experience with Software & Systems Reliability tools and methodologies (e.g. IEEE-1633)
Experience with software capability assessment methodologies (e.g. CMMI, ISO/IEC 12207, ISO/IEC 15504, etc.)
Relevant professional certifications (e.g. ASQ (CSQE), INCOSE, IEEE (PSEM, CSDP), CSSLP, CSM (Scrum Master), etc.)
Experience in the application of artificial intelligence/machine learning tools and methods to software quality systems and software development life cycles
Experience in the application of secure software development lifecycles and frameworks
Strong communication and leadership skills with ability to influence without authority
Experience influencing large-scale process adoption across multiple OUs or business groups
Benefits
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
BioWorld Financial Watch
2026-01-25
Company data provided by crunchbase